Study of SU11248 in Men With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.

SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.

SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.

This study is directed at two populations of men with advanced prostate cancer:

Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.

Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.

Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:

to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and

to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response [ Time Frame: were followed until disease progression, an average of 12 weeks ]

Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)

Secondary Outcome Measures :

Objective Responses, Defined as the Number of Participants With Complete or Partial Response [ Time Frame: Participants were followed until the time of disease progression, an average of 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.

Prostate Specific Antigen (PSA) > 5.0 ng/mL, based on PSA Working Group Criteria

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

For Group A only:

· No prior treatment for prostate cancer with cytotoxic chemotherapy

For Group B only:

Radiographic evidence of metastatic prostate cancer

One prior docetaxel-based chemotherapy regimen, minimum of two cycles

Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel

Exclusion Criteria:

Small cell carcinoma of the prostate

Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.

Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident

Receipt of any investigational anti-cancer agent within 4 weeks of the study

NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment

Uncontrolled hypertension

Prolongation of the QTc interval to > 450 msec

Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.